Quality Assurance Manager

3 weeks ago

Egham, Surrey, United Kingdom Essential Pharma Full time

Overview

Essential Pharma is in search of a Quality Assurance Manager with extensive knowledge of Good Manufacturing Practices (GMP). This role involves overseeing the quality assurance operations related to the outsourced manufacturing processes of Essential Pharma products, ensuring adherence to regulatory standards, and upholding superior product quality and safety. As the holder of market authorization, you will ensure that our obligations are met and that any quality-related issues concerning products are effectively managed.

Key Responsibilities

  • Reporting to the Associate Director of QA – GMP Operations, you will assist in maintaining the Quality Management System (QMS) in line with regulatory standards (e.g., FDA, EMA, ICH).
  • Ensure that all quality assurance processes and protocols are documented, adhered to, and subject to continuous enhancement.
  • Conduct internal and external audits and engage in regulatory inspections.
  • Guarantee that all products meet applicable regulations and guidelines.
  • Stay informed about updates in regulatory requirements and ensure prompt application of new regulations.
  • Prepare for and participate in regulatory inspections and audits, including visits to Contract Manufacturing Organizations (CMOs).
  • Manage risks, documentation, and reporting.
  • Collaborate with cross-functional teams, including manufacturing, supply chain, MSAT, R&D, and regulatory affairs, to ensure product quality throughout the product lifecycle.
  • Promote continuous improvement, training, and the integration of best practices within the quality framework across the organization.

Company Profile

Essential Pharma is a global specialty pharmaceutical organization committed to ensuring access to clinically distinct, niche medications for small patient populations. Our impactful portfolio encompasses over 300 medicines across ten therapeutic areas, focusing on the central nervous system (CNS), gastroenterology, ophthalmology, and rare diseases. Our products serve patients in more than 70 countries.

We proactively identify low-volume, challenging-to-manufacture therapeutic products and late-stage clinical development assets targeting rare diseases. Our recent acquisition of Renaissance Pharmaceuticals marks a significant achievement for Essential Pharma, adding a second product for treating a rare disease and the first development-stage asset to our portfolio.

Qualifications

  • Bachelor's degree in Pharmaceutical Science, Biologics, Biotechnology, Biochemistry, or a related discipline.
  • Demonstrated experience in quality assurance within the pharmaceutical sector, with essential experience in manufacturing operations of medicines; experience with biological products is advantageous.
  • In-depth understanding of Good Manufacturing Practices.
  • Strong communication and interpersonal abilities.
  • Capability to manage multiple projects and priorities in a dynamic environment.
  • Certification in quality assurance (e.g., ASQ Certified Quality Manager) is a plus.

Benefits

  • Competitive salary starting from £50,000.
  • Agile working environment offering flexibility and trust from the outset, with office attendance guided by business needs and role requirements.
  • £150 reimbursement for home office expenses.
  • Healthcare Insurance.
  • Pension scheme with a 5% employee contribution and a 3% employer match.
  • Life Insurance providing a tax-free death benefit of 4 times the basic salary.
  • Enhanced family leave and sick pay.
  • Annual leave of 26 days plus bank holidays, with additional time off during the holiday season.
  • Discretionary annual performance bonus.
  • Recognition program offering various incentives and awards.

Work Culture

We fully embrace agile working, understanding that it allows individuals to express their authentic selves. Our commitment to our values forms the foundation of our inclusive culture, where every voice is valued and respected. We foster a sense of autonomy and responsibility while nurturing our social nature through engaging activities and events. Our dedication to facilitating connections in the workplace is reflected in regular interactions with leadership. Grounded in principles of dynamism, responsibility, trustworthiness, and collaboration, our values guide our interactions. Additionally, our commitment to employee growth and learning is evident through personalized development plans, as we strive to create an environment where all individuals can flourish.

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